Utilizing VitaLink’s Site Network on a Global Phase IV Study

Case Study #2

Subject Enrollment

Challenge

Our sponsor came to us for completion of a Phase IV COPD program consisting of 3 studies. This case required global participation of 2,400 patients across 4 countries at 320 testing sites. Per the sponsor's original plan, only 6 to 8 subjects were allowed at any given facility and only 4 VitaLink sites were originally chosen. Due to this complexity and the required inclusion/exclusion criteria, enrollment lagged for the third study.

Solution

We stayed in close contact with the sponsor and worked together to up the number of VitaLink testing sites to 10. After a newly negotiated clinical trial agreement, we were able to offer better ease of entry for the sponsor across our standardized network. Thanks to VitaLink’s intense pre-screening, the sponsor saw an immediate decrease in screen failures.

Outcome

After switching to more VitaLink testing facilities, the sponsor was able to achieve results in record time. Total enrollment was 326- a 232% increase from the original ask and was completed 2 months ahead of schedule. The screen failure rate came in at 25%- a significant decrease from the expected 35%. The average VitaLink enrollment rate was 7-8x that of other sites participating in the study and the sponsor later decided to add an extra VitaLink facility thanks to the other sites performance.

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